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Diss Factsheets
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EC number: 950-969-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
No data on skin sensitization are available for the registered substance Santalene oil. The individual skin sensitization potential of each component present in Santalene oil was estimated in silico by the QSAR tool CaseUltra (version 1.7.0.5).
Three different models allow to discriminate between different potencies: 1) weak sensitizer (version 1.6.0.3.587.650); 2) moderate sensitizer (version 1.6.0.3.587.450); 3) extreme sensitizer (version 1.6.0.3.587.400). All calculations were found to be in the applicability domain of the respective model and were taken into account for the overall decision on the classification of Santalene oil. In summary, approx. 97% of all components present in the mixture have been assessed by this approach. Since a weak to moderate potential for skin sensitization was predicted for all structures, an overall classification as a skin sensitizer is indicated. The approach taken does not allow for a subcategorization into either 1A or B.
Substance
CaseUltra Model
Weak sensitizer
CaseUltra Model
Moderate sensitizer
CaseUltra Model
Extreme sensitizer
18252-46-5
positive
inconclusive
negative
512-61-8
positive
inconclusive
negative
13474-59-4
positive
inconclusive
negative
25532-78-9
positive
inconclusive
negative
18794-84-8
positive
inconclusive
negative
511-59-1
positive
inconclusive
negative
55123-21-2
positive
inconclusive
negative
495-61-4
positive
positive
negative
53585-13-0
positive
positive
negative
Furthermore, Santalene oil contains beta-Bisabolene (CAS 495-61-4) at concentrations between 1-4%. Bisabolene (isomers not specified; CAS 495-62-5) – tested in ethanol/water as a vehicle - was found to be a skin sensitizer in a LLNA, leading to an EC3 value of 8.6% (OECD 429; Givaudan, 2002; cited in the RIFM/FEMA database ID 41935). Accordingly, the constituent beta-Bisabolene (present in Santalene oil with concentrations >= 1%) shows skin sensitizing properties, which leads to a classification as skin sensitizer Cat. 1B.
Justification for classification or non-classification
Santalene oil contains components,which are predicted to be skin sensitizers. Furthermore, Santalene oil contains a component (classified as skin sensitizer Cat1B) at a concentration >=1%. Accordingly, Santalene oil fulfills the criteria laid down in regulation (EU) 1272/2008, and therefore, a classification with "Skin sensitisation" (Category 1) is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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